RESTORATION ADM X3 INS 28/52 1236-2-852

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-31 for RESTORATION ADM X3 INS 28/52 1236-2-852 manufactured by Stryker Orthopaedics-mahwah.

Event Text Entries

[188738325] Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: modular dual mobility insert; cat#: 626-00-46f; lot#: 75859604; c-taper cocr lfit head 28mm/+10; cat#: 06-2810; lot#: e424ev; ti sleeve for alumina head; cat#: 17-0000e; lot#: rj0y93. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[188738326] It was reported that the patient's right hip was revised. As reported by rep: "head and liner exchange due to post revision surgery fall and development of hematoma at the wound site. " an adm/mdm liner construct, 28 +10 c-taper head and sleeve were revised for devices of the same catalog numbers.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002249697-2020-00651
MDR Report Key9904228
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-11-22
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. COLLIN NEITZEL
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER ORTHOPAEDICS-CORK
Manufacturer StreetIDA INDUSTRIAL ESTATE
Manufacturer CityCARRIGTWOHILL NA
Manufacturer CountryIE
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESTORATION ADM X3 INS 28/52
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Product CodeMEH
Date Received2020-03-31
Model Number1236-2-852
Catalog Number1236-2-852
Lot Number75822401
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS-MAHWAH
Manufacturer Address325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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